159 Cases of Adverse Reactions to Immune Checkpoint Inhibitors

doi:10.19803/j.1672-8629.20240795

Abstract

Abstract: Objective To analyze the incidence and clinical characteristics of adverse drug reactions (ADR) associated with immune checkpoint inhibitors (ICIs) in order to provide a reference for safe clinical use of ICIs. Methods One hundred and fifty-nine ICIs-related ADR reports submitted between June 1, 2018 and August 31, 2024 in a cancer hospital were collected before the patients’ age, gender, severity of ADR, occurrence times, system organs involved, and clinical manifestations were analyzed. Results According to the 159 ADR reports, the age of most of the patients ranged from 41 to 70 (74.84%), and there were 1.94 times as many male patients as female ones. There were 11 types of ICIs medicines involved. 28.93% of these ADR were serious and 80.63% occurred in the first five cycles of ICIs therapy. ADR involved a wide range of system organ classes, particularly the skin and subcutaneous tissues. Six types of ICIs caused ADR that were not mentioned in drug inserts. Conclusion The spectrum of ADR caused by ICIs is extensive and complicated. The implementation of personalized risk-based surveillance strategies for early identification and intervention is critical to effective management of ICIs-related ADR.

Key words: Immune Checkpoint Inhibitor, Programmed Death 1 Inhibitor, Programmed Death Ligand 1 Inhibitor, Immune-Related Adverse Reaction, Adverse Drug Reaction, Safety

CLC Number:

ZHANG Yunhui, CHEN Haoyun, ZHONG Luhua, FANG Caifu, HUANG Huanjun, GUO Chenchen, DONG Xinyi, SHI Feng, LIANG Weiting. 159 Cases of Adverse Reactions to Immune Checkpoint Inhibitors[J]. Chinese Journal of Pharmacovigilance, 2025, 22(4): 442-446.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20240795

https://zgywjj.magtechjournal.com/EN/Y2025/V22/I4/442

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